mHealth for Phosphorus Management in CKD.

Dialysis Related Complication Clinical Trial

— PHOSFO_OK  

Official title:

mHealth System for the Self-control of Hyperphosphatemia in Patients With CKD.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05389826
• Other study ID #: PR291/21
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: September 2023
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project aims to generate an mHealth environment in which CKD patients are empowered in terms of the self-management of their hyperphosphatemia pathology, while under medical supervision. Such environment will allow nephrologists to inform patients beyond their traditional point-of-care and will allow patients to provide feedback on their condition in a timely manner that benefits the CKD collective. In this way we delve in a technological area that has been argued that remains underutilized within nephrology (1) and that should be perceived as an opportunity for CKD (2). In our work, we will build from recent related efforts in the control of hyperphosphatemia (3).

Description:

The working hypotheses are listed as follows:

1. Hyperphosphatemia is an important problem in the CKD realm, but difficult to manage because patients are often not aware of its importance. In addition, current clinical practice does not allow nephrologists to evaluate the patient's real understanding of their recommendations.

2. The patient could benefit from a smartphone-based interactive virtual assistant tool: an integrated personalized management system to achieve a form of participatory, personalized, predictive and preventive medicine in the specific domain of a pathology associated to CKD.

3. The combination of a flexible information channel with an interactive data visualization tool on mobile devices can be a most intuitive way to communicate with the patient, particularly if it allows comparison with other patients in similar situation. Additionally, data visualization can assist nephrologists in the clinical management of patients.

Primary Objective:

1-Analysis of the superiority of a Medical Mobile Application for Patient Support to educate CKD patients on how to self-manage their phosphate levels versus standard of care in lowering serum phosphorus by assessing changes in serum phosphorus comparing baseline with 6-months follow-up.

Secondary Objectives:

1. Adherence to treatment with phosphate binders.

2. Impact in Quality of Life of patients with CKD.

3. Satisfaction of such a tool.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 15, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1- Eligible patients will be stage 4-5 CKD patients, including end-stage renal disease (ESRD) on dialysis, aged >18 with hyperphosphatemia (serum phosphorus concentration >1.94 mmol/L) and stable dose of phosphate binders for >1 month before screening.

Exclusion Criteria:

1. Patients with intact parathyroid hormone concentration >800 ng/l (88 pmol/l) or if parathyroidectomy will be planned or expected.

2. Patients with significant gastro-intestinal (GI) or hepatic disorders.

3. Patients with major GI surgery.

Related Conditions & MeSH terms

• Dialysis Related Complication
• Hyperphosphatemia

Intervention

Device:
• mHealth App
We will compare the degree of improvement in phosphate control with respect to baseline values and report any adverse event. Nephrologist will use a web management system to provide results of phosphorus levels and medical recommendations to the patient, mediated by a cloud IT environment. In addition, patients will receive alerts, suggestions, and general information. They will also be able to communicate with nephrologists and interact with their corresponding group of fellow patients.

Locations

Country	Name	City	State
Spain	Hospital Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Vifor Pharma

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Chiang YC, Chang YP, Lin SC, Lin C, Hsu PH, Hsu YJ, Wu TJ. Effects of Individualized Dietary Phosphate Control Program With a Smartphone Application in Hemodialysis Patients in Taiwan. Biol Res Nurs. 2021 Jul;23(3):375-381. doi: 10.1177/1099800420975504. Epub 2020 Nov 28. — View Citation

Stauss M, Dhaygude A, Ponnusamy A, Myers M, Woywodt A. Remote digital urinalysis with smartphone technology as part of remote management of glomerular disease during the SARS-CoV-2 virus pandemic: single-centre experience in 25 patients. Clin Kidney J. 2021 Dec 21;15(5):903-911. doi: 10.1093/ckj/sfab286. eCollection 2022 May. — View Citation

Topf JM, Hiremath S. Got CKD? There's an App for That! Clin J Am Soc Nephrol. 2019 Apr 5;14(4):491-492. doi: 10.2215/CJN.02350219. Epub 2019 Mar 21. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the superiority of mobile-app and benchmarking versus standard of care in lowering serum phosphorus	Reduction of serum phosphorus by more than 0.5 mmol/L versus the standard of care testing.	6-months follow-up
Secondary	Adherence to phosphate binder's use and reduction in their use.	The ratio of current phosphate binders that the patient is swallowing compared to the number prescribed.	6-months follow-up
Secondary	Quality of life improvement	Health-related quality of life (HRQoL) will be assessed with the Short-Form 12 questionnaire (SF-12).	6-months follow-up
Secondary	Patient's and healthcare professionals' satisfaction with mobile health app to ensure its usability and promote patient retention	Satisfaction of patients will be assessed with the quality of care satisfaction in outpatient consultation questionnaire (EQS-C).	6-months follow-up